Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Status:
Recruiting
Trial end date:
2028-03-24
Target enrollment:
Participant gender:
Summary
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to
determine the efficacy of frexalimab in delaying the disability progression and the safety up
to approximately 51 months administration of study intervention compared to placebo in male
and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People
diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion
criteria and none of the exclusion criteria. Study details include:
- This event-driven study will have variable duration ranging from approximately 27 to 51
months.
- The study intervention duration will vary ranging from approximately 27 to 51 months.
- The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a
visit frequency of every month for the first 6 months and then every 3 months.